Royalty Report: Drugs, Therapeutic, Pharmaceuticals – Collection: 1006

Licensor grants to the Licensee of the Netherlands Antilles during the Term, an exclusive license, without the right to grant sublicenses, under Licensor IP and under Licensor's rights in the Joint Collaboration IP, to Develop, make, have made, use, sell, offer to sell, lease, import and export the Product in the U.S. Territory in the Field, and a non-exclusive license, with no right to grant sublicenses, under the Licensor's IP to make, have made, and use the Product in the Non-U.S. Territory, but only for the purposes of sale of the Product in or into the U.S. Territory; provided, however, that Licensor retains the right to practice, and to grant sublicenses, under Licensor IP and under Licensor's rights in the Joint Collaboration IP in the U.S. Territory in the Field to perform its obligations to the Licensees under this Agreement, including, without limitation, to conduct the Licensor activities under this Agreement and in the Annual Collaboration Plans and make and have made the Product in the U.S. Territory solely for the purposes of sales of the Product in the Field in those countries in the Non-U.S. Territory for which US Licensee does not, during the Non-U.S. Option Period, exercise the Non-U.S. Option, or if US Licensee exercises the Non-U.S. Option within the Non-U.S. Option Period, in those countries in the Non-U.S. Territory for which US Licensee and Licensor do not execute a Non-U.S. Territory Agreement either during the Initial Non-U.S. Territory Negotiation Period.

Licensor grants to either, but not both, of the Licensees the exclusive option to commence negotiations to obtain an exclusive license to Develop and Commercialize the Product in all or part of the Non-U.S. Territory.

The Company entered into a collaboration and License Agreement with another pharma to jointly develop and commercialize enoxaparin sodium injection, a generic version of Lovenox®, a low molecular weight heparin or LMWH.

Product means injectable enoxaparin and any improved injectable form of enoxaparin for which Lovenox®, as defined in the relevant New Drug Application approved as of the Effective Date or any past or future Supplemental New Drug Applications, is the reference listed drug and for which an ANDA could be approved by the FDA, but specifically excluding any Improved Enoxaparin.  

Lovenox® (enoxaparin) is a low molecular weight heparin, or LMWH.

The patents include Rationally Designed Heparinases Derived from Heparinase I and II, and,  System and Method for Notating Polymers, and, Novel Method for Sequence Determination using NMR, and, Methods and Products Related to Low Molecular Weight Heparin, and, The Heparinase Gene from Flavobacterium Heparinum, and, Delta 4, 5 Glycuronidase And Uses Thereof.

The Field means the injectable administration of the Product for any and all medical indications.  Lovenox® (enoxaparin) is used to prevent and treat deep vein thrombosis.

Pursuant to a separate agreement relating to the development and commercialization of enoxaparin, and, to characterize the generic enoxaparin for the purpose of obtaining regulatory approval.

Thereafter, Licensee incorporated the technology of the University into release testing of unfractionated heparin used in the manufacture of generic enoxaparin.

Enoxaparin is an anticoagulant that helps prevent the formation of blood clots.

University grants a first option to add Improvement to the Patent Rights, only in the fields for which exclusive rights, for six months after Company has been notified of the existence of each such Improvement.

Patent titles include Solid-and Solution-Phase Synthesis of Heparin and Other Glycosaminoglycans;  
Synthesis of Oligosaccharides in Solution and on the Solid Support;  Linkers for Synthesis of Oligosaccharides on Solid-Support;  Protecting Groups Useful in the Synthesis of Polysaccharides, Natural Products, and Combinatorial Libraries;  Apparatus and Methods for the Automated Synthesis of Oligosaccharides;   Rationally Designed Heparinases Derived from Heparinase I and II;   System and Method for Notating Polymers;  and, Method for Identifying or Characterizing Properties of Polymeric Units.

The Field Therapeutics shall mean for internal use in the discovery and development of therapeutic compounds;  and,  the clinical testing, manufacture and sale of therapeutic compounds.  This field shall not include the sale of research reagents or of synthesis machines.

The Field Heparinase shall mean all fields of use except for human use of heparinases as therapeutics in pharmaceutical compositions and except for Field Sequencing Machines.

University grants to Licensee a first option to add improvements to the Patent Rights, only in the fields for which exclusive rights are granted.

Heparanase, also known as HPSE, is an enzyme that acts both at the cell-surface and within the extracellular matrix to degrade polymeric heparan sulfate molecules into shorter chain length oligosaccharides.

Licensee is also utilizing our ability to sequence, or analyze the molecular structure of, sugars, to create generic versions of complex sugar-based drugs, or technology-enabled generic products. Through detailed analysis of the molecular structure of complex sugars, our technology provides a more complete understanding of the roles that sugars play in cellular function, disease and drug action. Based on our understanding of complex sugars, Licensee has developed a diversified pipeline of novel discovery and development candidates and near-term product opportunities.